BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS 200 S/C

    MDR report key: 8961028 · Received September 4, 2019

    Report

    Report Number
    1213809-2019-00884
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 13, 2019
    Report Date
    October 16, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096597
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWENTY-THREE LOOSE 1ML SYRINGES WERE RECEIVED AND EVALUATED. THE "WHITE RESIDUE" IN THE SYRINGES APPEARED TO BE SILICONE AND WAS THE NORMAL AND EXPECTED AMOUNT PER PRODUCT SPECIFICATION. IT WAS OBSERVED ALL THE SYRINGE WERE OBSERVED TO HAVE CLOUDY TIPS. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. CLOUDY TIPS ARE A RESULT OF NORMAL MOLDING PROCESS. OVER TIME A SMALL AMOUNT OF PLASTIC BUILD UP OR RESIDUE OCCURS IN THE MOLD CAUSING THIS DEFECT. IT IS REMEDIED BY POLISHING THE MOLD. THE CLOUDY TIP DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE 1ML LS 200 S/C. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT SYRINGES CONTAINED WHITE RESIDUE. PER EMAIL: DID ALL 70,500 SYRINGES CONTAIN THE WHITE RESIDUE? WE FOUND 740 SUCH DEFECTS OUT OF 1455 INSPECTED UNITS. THESE SPAN ACROSS LOT 9091734, 9037717, 9037699, 9127543, AND 9046821. 100% INSPECTION IS UNFEASIBLE DUE TO THE NATURE OF THE TESTING. UPDATED INFO: I ALSO WANT TO SHARE WITH YOU ON THE CLOUDY SUBSTANCE INVESTIGATION ASSOCIATED WITH (B)(4). OUR LINE AUDITOR DID SOME IN-HOUSE INSPECTION AND WAS ABLE TO VISUALIZE THE INTERIOR LUMEN OF THE SYRINGES THAT HAD VISIBLE CLOUDINESS EMBEDDED IN THE SYRINGE BARRELS. THE CLOUDINESS WAS NOT MOBILIZED NOR VISIBLY RELEASED INTO THE FLUID PATHWAY WITH PHYSICAL SCRAPING OR IMMERSION IN ALCOHOL. IT APPEARS TO BE A PART OF THE PLASTIC MOLDING, NOT ON THE SURFACE OF THE LUMEN." THIS IS 1 OF 2 COMPLAINTS. THE OTHER LOT #S 9091734, 9037717, 9037699, 9127543 AND THEIR PRODUCT INFORMATION ARE CONTAINED IN THE OTHER COMPLAINT (MFR REPORT # 1213809-2019-00832).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE 1ML LS 200 S/C. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT SYRINGES CONTAINED WHITE RESIDUE. PER EMAIL: DID ALL 70,500 SYRINGES CONTAIN THE WHITE RESIDUE? WE FOUND 740 SUCH DEFECTS OUT OF 1455 INSPECTED UNITS. THESE SPAN ACROSS LOT 9091734, 9037717, 9037699, 9127543, AND 9046821. 100% INSPECTION IS UNFEASIBLE DUE TO THE NATURE OF THE TESTING. UPDATED INFO: I ALSO WANT TO SHARE WITH YOU ON THE CLOUDY SUBSTANCE INVESTIGATION ASSOCIATED WITH PR 1119948 AND PR 1093227. OUR LINE AUDITOR DID SOME IN-HOUSE INSPECTION AND WAS ABLE TO VISUALIZE THE INTERIOR LUMEN OF THE SYRINGES THAT HAD VISIBLE CLOUDINESS EMBEDDED IN THE SYRINGE BARRELS. THE CLOUDINESS WAS NOT MOBILIZED NOR VISIBLY RELEASED INTO THE FLUID PATHWAY WITH PHYSICAL SCRAPING OR IMMERSION IN ALCOHOL. IT APPEARS TO BE A PART OF THE PLASTIC MOLDING, NOT ON THE SURFACE OF THE LUMEN." THIS IS 1 OF 2 COMPLAINTS. THE OTHER LOT #S 9091734, 9037717, 9037699, 9127543 AND THEIR PRODUCT INFORMATION ARE CONTAINED IN THE OTHER COMPLAINT (MFR REPORT # 1213809-2019-00832).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753710 SYRINGE 1ML LS 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9046821 30382903096597

    Patients

    Seq Age Sex Outcome Treatment
    1 Other